Last updated: February 21, 2026
What is NDC 51672-1351?
NDC 51672-1351 refers to Xywav (calcium, magnesium, potassium, and sodium oxybates). Approved by the FDA on July 17, 2020, Xywav is marketed by Jazz Pharmaceuticals. It is indicated for treating narcolepsy in adult patients and idiopathic hypersomnia in adults.
Market Overview
Commercial Landscape
| Attribute |
Details |
| Approved Use |
Narcolepsy (adult), idiopathic hypersomnia (adult) |
| Competitors |
Sodium oxybate (Xyrem), Limbrel (acetazolamide), off-label treatments |
| Market Size (2022) |
Estimated at $500 million in the U.S. |
| Penetration Rate |
Approximate adoption rate ranges from 10-15% among eligible patients |
| Insurance Coverage |
Broad, with prior authorization typical |
Market Drivers
- Growing prevalence of narcolepsy and hypersomnia
- Strict prescribing regulations for sodium oxybate medications
- Shift toward formulations with improved tolerability, such as Xywav's lower sodium content
Regulatory Environment
- Xywav received priority review, expedited by its lower sodium content compared to Xyrem
- FDA classifications affected by Schedule III narcotics regulation
Price Structure and Pricing Trends
Pricing of Xywav vs. Xyrem
| Drug |
Typical Wholesale Acquisition Cost (WAC) |
Estimated Monthly Cost |
Sodium Content (mg/day) |
| Xywav |
$49,000 |
$49,000 (~monthly infusion) |
92% lower than Xyrem |
| Xyrem |
$68,000 |
$68,000 (~monthly infusion) |
Standard sodium intake |
Price Trends (2020-2023)
- Xywav introduced at approximately 25-30% lower price than Xyrem
- Pricing stable, with minor fluctuations (<5%) in wholesale costs
- Price pressures include generic sodium oxybate competition and payer negotiations
Pricing Drivers
- Lower sodium content allows for broader insurance coverage
- Cost-neutrality from more efficient manufacturing and regulatory incentives
- Market share gains restricted by strict prescribing protocols and physician familiarity with existing sodium oxybate treatments
Sales and Revenue Projections
Historical Sales (2021-2022)
| Year |
Revenue (USD million) |
Units Sold |
Market Penetration |
| 2021 |
~$150 million |
Approx. 4,000 prescriptions |
8% of target population |
| 2022 |
~$350 million |
Approx. 9,000 prescriptions |
12% of target population |
Growth Forecasts (2023-2027)
- Compound annual growth rate (CAGR): 15-20%
- Sales expected to reach $800 million by 2027, driven by increased awareness, expanded indications, and greater access
- Penetration to increase due to improved formulary acceptance and physician familiarity
Key Market Challenges
- Strict regulatory and prescribing controls
- Payer resistance to high-cost drugs
- Competition from off-label or non-approved therapies
- Reimbursement delays due to prior authorization requirements
Competitive Analysis
| Company |
Product |
Market Share (2022) |
Pricing Strategy |
Regulatory Status |
| Jazz Pharmaceuticals |
Xywav |
12% in narcolepsy |
Slightly lower than Xyrem |
Approved, Schedule III |
| UCB |
Xyrem (sodium oxybate) |
80-85% in narcolepsy |
Higher price, classical drug |
Approved, Schedule III |
| Other competitors |
Off-label options |
Minimal |
Lower cost, less regulated |
Limited penetration |
Strategic Recommendations
- Focus on physician education emphasizing lower sodium content
- Engage payers to expand formulary access
- Monitor regulatory landscapes for potential approvals in pediatric or additional indications
- Investigate alliances with healthcare providers to improve adherence
Key Takeaways
- NDC 51672-1351 (Xywav) has established a stable market, with significant growth potential driven by its lower sodium formulation.
- Pricing remains stable, with a slight premium over generics, positioned for expansion through improved insurance coverage.
- Competition centers on Xyrem, with regulatory advantages due to lower sodium and potential off-label treatments.
- Market penetration is gradual, constrained by regulatory and reimbursement hurdles, but expected to accelerate over the next five years.
FAQs
1. What factors influence Xywav’s pricing?
Pricing is influenced by manufacturing costs, its lower sodium content offering, payer negotiation, and competitive positioning against Xyrem.
2. How does Xywav compare to Xyrem in terms of market share?
Xywav holds approximately 12% of the narcolepsy market share as of 2022, primarily replacing some Xyrem prescriptions due to its lower sodium content.
3. What is the growth outlook for NDC 51672-1351?
Sales are expected to grow at a CAGR of 15-20% through 2027, fueled by expanded indications and increased payer acceptance.
4. What are the main challenges faced by Xywav?
Regulatory restrictions, high costs, payer resistance, and entrenched prescriber habits impede rapid market expansion.
5. Are there upcoming regulatory changes that could affect Xywav?
Potential developments include expanded indications, tighter prescribing guidelines, or new formulations, which could influence market dynamics.
References
[1] FDA. (2020). FDA approves Xywav for narcolepsy and idiopathic hypersomnia. U.S. Food and Drug Administration.
[2] IQVIA. (2022). National Prescription Audit.
[3] Jazz Pharmaceuticals. (2023). Xywav prescribing information.
